GLUCAGON kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

GLUCAGON (UNII: 76LA80IG2G) (GLUCAGON - UNII:76LA80IG2G)

Available from:

Amphastar Pharmaceuticals, Inc.

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

BECOME FAMILIAR WITH THE FOLLOWING INSTRUCTIONS BEFORE AN EMERGENCY ARISES. DO NOT USE THIS KIT AFTER DATE STAMPED ON THE VIAL OF GLUCAGON. IF YOU HAVE QUESTIONS CONCERNING THE USE OF THIS PRODUCT, CONSULT A DOCTOR, NURSE OR PHARMACIST. Make sure that your relatives or close friends know that if you become unconscious, medical assistance must always be sought. Glucagon may have been prescribed so that members of your household can give the injection if you become severely hypoglycemic and are unable to take sugar by mouth. If you are unconscious, glucagon can be given while awaiting medical assistance. Show your family members and others where you keep this kit and how to use it. They need to know how to use it before you need it. They can practice giving a shot by giving you your normal insulin shots. It is important that they practice. A person who has never given a shot probably will not be able to do it in an emergency. IMPORTANT - Act quickly. Prolonged unconsciousness may be harmful. - These simple inst

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GLUCAGON- GLUCAGON
AMPHASTAR PHARMACEUTICALS, INC.
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INFORMATION FOR THE PHYSICIAN
GLUCAGON FOR INJECTION
Rx Only
DESCRIPTION
Glucagon for Injection (synthetic origin) is a polypeptide hormone
identical to human glucagon that
increases blood glucose and relaxes smooth muscle of the
gastrointestinal tract. Glucagon is produced
by solid state peptide synthesis and is highly purified.
Glucagon is a single-chain polypeptide that contains 29 amino acid
residues and has a molecular weight
of 3483.
The empirical formula is C
H
SN O S. The primary sequence of glucagon is shown below.
Crystalline glucagon (synthetic origin) is a white to off-white
powder. It is relatively insoluble in water
but is soluble at a pH of less than 3 or more than 9.5.
Glucagon is available for use intravenously, intramuscularly, or
subcutaneously in a kit that contains a
vial of sterile glucagon and a syringe of sterile diluent. The vial
contains 1 mg of glucagon and 49 mg
of lactose. Hydrochloric acid may have been added during manufacture
to adjust the pH of the
glucagon. One International Unit of glucagon is equivalent to 1 mg of
glucagon.1 The diluent syringe
contains 12 mg/mL of glycerin, Water For Injection, and hydrochloric
acid.
CLINICAL PHARMACOLOGY
Glucagon increases blood glucose concentration and is used in the
treatment of severe hypoglycemia.
Glucagon acts only on liver glycogen, converting it to glucose.
Glucagon administered through a parenteral route relaxes smooth muscle
of the stomach, duodenum,
small bowel, and colon.
PHARMACOKINETICS
Glucagon has been studied following intramuscular, subcutaneous, and
intravenous administration in
adult volunteers. Administration of the intravenous glucagon showed
dose proportionality of the
pharmacokinetics between 0.25 and 2.0 mg. Calculations from a 1 mg
dose showed a small volume of
distribution (mean, 0.25 L/kg) and a moderate clearance (mean, 13.5
mL/min/kg). The half-life was short,
153
225
43
49
ranging from 8 to 18 minutes.
Maximum plasma concentrations of 7.9 ng/mL were a